A program providing fruit and vegetable prescriptions for diabetes management
A Pilot, 3-arm Randomized Controlled Trial of a Fruit and Vegetable Prescription Program for Patients With Type Two Diabetes
This study is testing whether giving low-income Hispanic adults with Type 2 diabetes vouchers for fruits and vegetables, along with diabetes education, can help them manage their condition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Reading, Pennsylvania) |
| Trial ID | NCT06107816 on ClinicalTrials.gov |
What this trial studies
This program aims to improve diabetes management among Hispanic adults by providing vouchers for fruits and vegetables (F&V) through a prescription model. It targets patients with Type 2 Diabetes Mellitus (T2DM) who are low-income and have not previously engaged in diabetes self-management education. The intervention includes usual care, F&V prescriptions alone, and F&V prescriptions combined with diabetes self-management education and support (DSME/S). The study will assess the impact on dietary intake, glucose control, and program implementation outcomes.
Who should consider this trial
Good fit: Ideal candidates are low-income Hispanic adults diagnosed with Type 2 Diabetes Mellitus for at least six months and with an A1c level of 7% or higher.
Not a fit: Patients who have recently participated in similar programs or who have uncontrolled mental illness or substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve dietary habits and glucose control in patients with Type 2 Diabetes Mellitus.
How similar studies have performed: Preliminary studies of similar F&V prescription programs have shown positive outcomes, including increased fruit and vegetable intake and reductions in hemoglobin A1c levels.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient at Penn State Health St. Joe's Medical Center * Diagnosis of Type 2 Diabetes Mellitus greater than or equal to six months * A1c level is greater than or equal to 7% (53 mmol/mol) * Low income defined as enrolled in Supplemental Nutrition Assistance Program (SNAP), is uninsured or have Medicaid, or identifying as food insecure based on USDA criteria. * Ability to give a blood sample * Willing to respond to contacts from study staff over the study period * Willing and able to give informed consent * Can read and write in English or Spanish Exclusion Criteria: * Diagnosis of Type 2 Diabetes Mellitus less than six months * Patients who have previously participated in the Veggie Rx program in the past year * Patients who have attended any diabetes self-management education and support (DSME/S) sessions in the past year * Women who are pregnant or who plan to become pregnant during the study period * Any uncontrolled mental illness or substance abuse, or inpatient treatment for these in the past six months * Any unstable or significant medical condition in the past 3 months (e.g. recent heart attack, stroke, DVT) * A1c level is less than 7% * Does not speak English or Spanish * Inability to provide informed consent * Unable to give a blood sample
Where this trial is running
Reading, Pennsylvania
- Penn State Health St. Joseph Downtown Campus — Reading, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Susan Veldheer, DEd, RD — Penn State College of Medicine
- Study coordinator: Susan Veldheer, DEd, RD
- Email: sveldheer@pennstatehealth.psu.edu
- Phone: 717-531-5625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.